Preservation of von Willebrand Factor Activity With the ModulHeart Device.

von Willebrand Factor (VWF) destruction is common with current heart pumps. This study evaluates VWF activity with ModulHeart, a novel device using 3 micropumps in parallel. In model 1, ModulHeart was compared with Impella devices in vitro. In model 2, 3 healthy swine received ModulHeart. Model 3 includes VWF data from patients who underwent protected percutaneous coronary intervention with ModulHeart. In models 1, 2, and 3, ModulHeart resulted in preservation of VWF, whereas there was a 27% and 19% reduction in VWF activity with the Impella CP and 5.0, respectively. ModulHeart features a unique design and demonstrated preservation of VWF activity.

Real-World Management Strategies of Anticoagulated Atrial Fibrillation Patients After a Clinically Significant Bleeding Episode.

BACKGROUND: Systemic anticoagulation for stroke prevention in patients with atrial fibrillation (AF) carries inherent bleeding risks, and determining whether and when to resume anticoagulation after significant bleeding is a common dilemma. We aimed to describe the clinical characteristics of AF patients discharged after a bleeding event, document real-life thromboembolic prevention strategy (TPS), and analyse their associated clinical outcomes. METHODS: We retrospectively reviewed the charts of anticoagulated AF patients admitted for bleeding from 2017 to 2019. RESULTS: A total of 140 patients were included, with a mean age of 78.6 years. Four discharge groups were defined: 75 patients (53.5%) had optimal anticoagulation (OA), 37 (26.4%) had a suboptimal antithrombotic regimen (SAR; low-dose direct oral anticoagulants without dose-reduction criteria or antiplatelet therapy), 10 (7.1%) were referred for left atrial appendage occlusion (LAAO), and 18 (12.9%) left without any TPS. All-cause mortality at 2 years was high (28.6%) but not statistically different between groups (P = 0.71). Patients discharged with a TPS (OA/SAR/LAAO referral) were more likely to be readmitted for bleeding at 2 years (34% vs 0%; P = 0.002), and those discharged without a TPS had higher rates of stroke (16.6% vs 1.4%; P = 0.003). SAR yielded readmission rates for bleeding similar to resumption of OA (27% vs 34.7%; P = 0.41) but was associated with high rates of death or readmission at 2 years. CONCLUSIONS: This real-life cohort reveals that clinicians frequently downgrade or discontinue long-term thromboembolic protection after a bleeding event despite current guideline recommendations to the contrary, and downgrading resulted in bleeding risk similar to OA.

Organ blood flow assessment with the ModulHeart cardiorenal support device.

BACKGROUND: ModulHeart (Puzzle Medical Devices Inc) is a novel percutaneous flow entrainment pump anchored in the descending aorta. The current study evaluates the hemodynamic effect of ModulHeart support and its impact on cerebral, myocardial, and renal blood flow. METHODS: ModulHeart was implanted in the descending aorta of four healthy calves. A ramp protocol (2000 RPM increments) was performed with the pump operating at five different speeds from 14 000 to 22 000 RPM. For each speed, pressures proximal and distal to the pump, and right heart catheterization measurements were recorded. Stable-isotope labeled microspheres were injected in the left ventricle to evaluate organ perfusion. RESULTS: Thermodilution cardiac output increased by 23% at 22 000 RPM. Greater pump speeds resulted in greater pump gradients, up to 10 mm Hg in mean arterial pressure at 22 000 RPM, without significant reduction of proximal perfusion pressures. Arterial pulse pressure remained stable at all speeds. ModulHeart was not associated with a reduction in cerebral or myocardial blood flow at any speed. Renal cortical and medullary blood flow increased by up to 50% and 40%, respectively. CONCLUSION: The ModulHeart device implanted in the descending aorta of healthy calves resulted in significant arterial pressure gradients and preserved pulse pressure. Greater pump speeds translated into greater increases in renal blood flow, with no decrease in cerebral or myocardial perfusion.

Correlation between measured and predicted mismatch with valve hemodynamics in transcatheter aortic valve replacement: A sex-based analysis.

BACKGROUND: Data regarding the reliability of predicted effective orifice area indexed (pEOAi) is scarce in transcatheter aortic valve replacement (TAVR). AIMS: To assess the validity of the pEOAi in TAVR by correlating its value with echocardiography-derived hemodynamic data. METHODS: A single-center retrospective cohort study of TAVR patients from 2012 to 2021 with available echocardiograms was conducted. Patient-prosthesis mismatch (PPM) was defined based on the Valve Academic Research Consortium 3 criteria. The main endpoints were the congruence of measured effective orifice area indexed (EOAi) and pEOAi with the hemodynamic data obtained by echocardiography. The secondary endpoint included a correlation of predicted PPM (pPPM) and measured PPM (mPPM) with postoperative New York Heart Association (NYHA) status. RESULTS: A total of 318 patients were included. pPPM was more frequent than mPPM (54 [17%]; all moderate PPM vs. 39 [12.3%]: 32 moderate and 7 severe PPM). Predicted and measured EOAi were statistically correlated with postprocedural transvalvular mean gradient and Doppler velocity index (all p < 0.001), including in both sex-based subgroups. The positive predictive value and negative predictive value (NPV) of pPPM for postprocedural transvalvular mean gradient ≥ 20 mmHg were 16% and 97%, respectively. Only pPPM was significantly more prevalent in the group in which NYHA failed to improve than in those with symptom improvement (30.1% vs. 16%, p = 0.027). CONCLUSION: Predicted PPM has an excellent NPV for postprocedural transvalvular mean gradient ≥ 20 mmHg and seems to be a good predictor of NYHA status evolution as opposed to measured PPM. Predicted EOAi can be used in procedural planning to reduce the risk of PPM in both TAVR male and female patients.

The Use of Three-Dimensional Printing in Cardiac Structural Disease: A Review.

OBJECTIVE: Three-dimensional printing (3DP), or additive fabrication, is a process in which a physical 3D model is created using a multitude of 2-dimensional images. This process has been applied to numerous surgical subspecialties with growing interest for the use of 3DP in adult structural heart disease. This scoping review evaluates the use of 3DP in transcatheter and surgical aortic and mitral valve interventions as well as left atrial appendage occlusion in terms of its practical and clinical application. METHODS: Articles were identified through PubMed and Embase using MeSH search terms as well as independent searches. A total of 645 articles were screened, and 37 were retained for qualitative analysis. RESULTS: Operative planning was coded in 100% of articles, complication prevention in 43%, medical education in 5.4%, patient education in 0%, and simulation in 5.4%. CONCLUSIONS: The main uses of 3DP in acquired structural heart disease are centered around operative planning and complication prevention, with moderate use regarding surgical simulation and infrequent use regarding medical and/or patient education. Although patient anatomy varies greatly, deploying 3DP as a large-scale tool remains a possibility. The more 3D models are made, the more can be learned about demographic subsets of patient populations. Due to the lack of standard operating procedures for the creation of 3DP models, the cost-effectiveness of these models is hard to determine and likely center specific. More research into this facet could inform centers that wish to implement this tool.

Transcatheter occlusion of a left ventricular outflow tract pseudoaneurysm using a "plug and coil" strategy.

Left ventricular outflow tract pseudoaneurysm is a rare and potentially fatal complication of aortic valve replacement. Surgical repair is the most common treatment and is particularly suitable for large pseudoaneurysms. Recently, there has been significant breakthroughs in the management of postoperative pseudoaneurysms via endovascular techniques. We report a case of a large postoperative pseudoaneurysm of the left ventricular outflow tract that occurred 1 year following a redo mechanical aortic valve replacement in a patient with previous valve sparing procedure performed 5 years earlier. The pseudoaneurysm was anatomically located antero-laterally between the right atrium and the ascending aorta. Successful occlusion was achieved with an Amplatzer Vascular Plug 2 (Abbott) and several coils (Terumo) via a transapical approach.

Closing the door in front of a torrential mitral regurgitation.

BACKGROUND: Treatment of symptomatic severe mitral regurgitation (MR) is challenging in patients who are not candidates for surgical intervention. CASE DESCRIPTION: We report the case of a 64-year-old female with multiple comorbidities who was found to have severe MR due to a large mitral valve non coaptation. CONCLUSIONS: In this case report, we show the potential of transcatheter edge-to-edge mitral valve repair using MitraClip for the treatment of torrential MR due to a large mitral valve non-coaptation in a patient with no prior history of coronary artery disease and in whom surgical intervention was not an option.

Percutaneous Treatment of Concomitant Severe Aortic Stenosis and Thoracoabdominal Aortic Aneurysm.

PURPOSE: Although rare in occurrence, symptomatic severe aortic stenosis and large thoracoabdominal aortic aneurysm (TAAA) found in combination pose a real therapeutic challenge, especially in elderly frail patients. Surgical approaches for combined treatment are complex and at high risk of complications while staged procedures carry the risk of an unfavorable evolution of the condition temporarily left untreated. Minimally invasive approaches may therefore prove a more suitable strategy for these patients. CASE REPORT: We present the case of a 78-year-old woman with symptomatic severe aortic stenosis (AS) and a TAAA of 7.8 cm in diameter. Transcatheter treatment of both conditions was successfully performed in a staged manner. The first intervention consisted of combined transfemoral transcatheter aortic valve implantation (TAVI) immediately followed by a zone 3 thoracic endovascular aortic endoprosthesis deployment. In order to reduce the extent of intercostal arteries coverage and mitigate the risk of medullar ischemia, a second-stage percutaneous endovascular treatment of the TAAA was performed with a customized 4-fenestration prosthesis. Early and 12-month clinical and radiologic follow-up were favorable. CONCLUSION: This case demonstrates how a strong multidisciplinary collaboration allows for successful resolution of complex clinical scenarios.

Assessing the Accuracy of a Second-Generation Optical Sensor Pressure Wire in a Wire-to-Wire Comparison (The ACCURACY Study).

BACKGROUND: The phenomenon of "pressure drift" increases uncertainty about the correct FFR value. Redesigned and incorporating an optical pressure sensor, the "OptoWire Deux™" is purported to be less prone to the pressure drift seen with piezoelectric coronary pressure wires. The aim of this first in vivo real-world clinical study is to evaluate the performance of OptoWire Deux™ in terms of measurements agreement and propensity to pressure drift in a wire to wire comparison. METHODS: This is a single center, prospective, non-blinded clinical investigation enrolling 45 consecutive patients with a clinical indication for coronary lesion FFR assessment. Lesions were either simultaneously assessed with two optical sensor pressure wires (OSPW) (Group O-O; 30 patients, 34 lesions) or one OSPW and one piezoelectric pressure wire (PEPW) simultaneously (Group O-P; 15 patients, 15 lesions). Significant drift was defined as a pressure ratio deviation of >0.03. RESULTS: Mean FFR measurements in Group OO were not statistically different between the two sets of OSPW (overall 0.84±0.10; P = 0.52). In Group OP, however, mean FFR measurement with PEPW (0.85±0.09) was numerically lower than that observed with the OSPW (0.88±0.08; P = 0.09). Level of agreement using the Bland-Altman method was higher when 2 OSPW were used for FFR assessment (-0.002 95% CI [-0.033,0.029] vs. 0.026 95% CI [-0.078, 0.130], respectively). The rate of drift was significantly lower with an OSPW compared to a PEPW (4.8% vs. 26.7% respectively, P = 0.02). CONCLUSION: The optical sensor guidewire showed a high level of readings' agreement after simultaneous usage of 2 optical sensor guidewires. There was also significantly less drift when compared to a piezoelectric guidewire.

Does "Obesity Paradox" Apply for Patients Undergoing Transcatheter Aortic Valve Replacement?

BACKGROUND: Data is controversial regarding the existence of an "obesity paradox" in patients undergoing Transcatheter Aortic Valve Replacement (TAVR). We sought to investigate the prognostic value of the body mass index (BMI) on outcomes following TAVR. METHODS: This is an observational, single-center study involving all patients who underwent TAVR from 2009 to 2019. BMI was calculated in all patients before TAVR. The cohort was subdivided into four groups: underweight (<20 kg/m2), normal weight (≥20 to <25 kg/m2), overweight (≥25 to <30 kg/m2) and obese (≥30 kg/m2). The main endpoint was all-cause 30-day and one-year mortality. RESULTS: A total of 412 patients (mean age 79.6 ± 7.8 years, mean STS score 5.3 ± 3.6) were included. Patients were grouped as follows: underweight (n = 35, 8.5%), normal weight (n = 121, 29.4%), overweight (n = 140, 34%) and obese (n = 116, 28.1%). Obese patients were younger, included more females and had lower STS score than the rest of the cohort whereas underweight patients were older, had higher STS score, more chronic kidney disease, more left ventricular dysfunction and more often underwent non-transfemoral TAVR. BMI predicted 30-day survival (AUC:0.692 [95%CI 0.522-0.862]; p = 0.030) with an optimal cut-off of 24.4 (sensitivity = 66.6%, specificity = 63.6%). On multivariate analysis, higher BMI trended toward lower 30-day mortality (HR = 0.87 [95%CI 0.75-1.01]; p = 0.071). Thirty-day mortality was higher in the underweight group (8.3%) in comparison with other BMI subgroups (normal weight 2.5%, overweight 1.4%, obese 0.9%; p = 0.045). However, no significant difference was found after adjustment of confounders (all p = NS). BMI did not predict one-year mortality. No significant difference in one-year survival was observed between the four BMI subgroups (log rank p = 0.925). CONCLUSION: BMI could represent an interesting prognostic tool for short-term mortality in patients undergoing TAVR. BMI < 20 kg/m2 was associated with higher 30-day mortality. Symptoms improved similarly in obese patients compared to lower BMI patients. For 30-day survivors, no evidence of the existence of an obesity paradox was observed in this cohort.

Challenging Diagnosis of Patent Foramen Ovale in Presence of a Large Eustachian Valve.

We report the case of a 39-year-old woman who presented with cryptogenic stroke. Conventional and contrast echocardiography modalities noticed a large Eustachian valve (EV) but failed to identify any right-to-left shunt. Conversely, contrast-transcranial Doppler revealed a grade 3 right-to-left shunt. Contrast echocardiography was repeated with bubble injections through both an upper extremity and a femoral vein, 10 min apart from each other. While no shunt was observed following upper extremity injection, >20 bubbles crossed the inter-atrial septum when contrast was injected via femoral vein confirming the diagnosis of patent foramen ovale.

Changes in outcomes over time in intermediate-risk patients treated for severe aortic stenosis.

BACKGROUND: The advent of transcatheter aortic valve replacement (TAVR) has changed the practice of treating patients with severe aortic stenosis (AS). Heart-Teams have improved their decision-making process to refer patients to the best and safest treatment. The evidence allowed centers to increase funding and TAVR volume and extend indications to different risk categories of patients. This study evaluates the outcomes of intermediate-risk patients treated for severe AS in an academic center. METHODS: Between 2012 and 2019, 812 patients with AS underwent TAVR or surgical aortic valve replacement (SAVR). A propensity score-matching analytic strategy was used to balance groups and adjust for time periods. Outcomes were recorded according to the Society of Thoracic Surgeons Guidelines; the primary outcome being 30-day mortality and the secondary outcomes being perioperative course and complications. RESULTS: No difference in mortality was seen but complications differed: more postoperative transient ischemic attacks, permanent pacemaker implantations, and perivalvular leaks in the transcatheter group, while more acute kidney injuries, atrial fibrillation, delirium, postoperative infections and bleeding, tamponade and need for reoperation in the surgical group as well as a longer hospital length-of-stay. However, over the years, morbidities/mortality decreased for all patients treated for AS. CONCLUSIONS: Data showed an improvement in morbidities/mortality for intermediate-risk patients treated with SAVR or TAVR. Increased funding allowed for a higher TAVR volume by increasing access to this technology. Also, the difference in complications could impact healthcare costs. By incorporating important metrics such as length-of-stay, readmission rates, and complications into decision-making, the Heart-Team can improve clinical outcomes, healthcare economics, and resource utilization.

Successful Treatment of a Stenotic Pulmonary Vein to Left Atrium Conduit With a Drug-Eluting Stent.

Partial anomaly of the pulmonary venous return is a rare congenital condition treated with surgical redirection of the blood flow through the creation of a conduit to the left atrium. We report the case of a stenotic pulmonary vein to left atrium conduit successfully treated with the implantation of a drug-eluting stent. Pulmonary vein or conduit stenosis is generally treated with balloon dilation or bare-metal stent but is often met with underwhelming outcomes. Given the successful outcome of the case presented, drug-eluting stents may represent an attractive treatment option in suitable anatomies.

Les anomalies partielles du retour veineux pulmonaire sont des anomalies congénitales rares traitées par une intervention chirurgicale visant à rediriger le flux sanguin par la création d'un conduit vers l'oreillette gauche. Nous rapportons un cas de veine pulmonaire sténosée au conduit de l'oreillette gauche pour laquelle l'implantation d'une endoprothèse médicamentée s'est avérée une réussite. La sténose de la veine pulmonaire ou du conduit est généralement traitée par la dilation par ballonnet ou l'implantation d'une endoprothèse non médicamentée nu, mais les résultats sont souvent décevants. Compte tenu des résultats favorables observés pour ce cas, les endoprothèses à élution de médicamentées peuvent constituer une option attrayante de traitement dans les cas où l'anatomie s'y prête.

Valve-in-Valve Implantation of a Sapien 3 Transcatheter Heart Valve for Reduction of Paravalvular Regurgitation Despite Optimal Placement of the First Transcatheter Heart Valve.

Valve-in-valve implantation is generally successful in reducing paravalvular regurgitation (PVR) in cases in which the first transcatheter heart valve is deployed in a suboptimal location. We describe a case of severe PVR 2 months after implantation of a 26-mm Sapien XT valve (Edwards Lifesciences Inc, Irvine, CA) in the optimal location. Valve-in-valve implantation of a Sapien 3 valve (Edwards Lifesciences Inc), and enough left ventricular outflow tract tissue at the inflow edge the Sapien XT to appose the sealing cuff of the Sapien 3 combined for successful PVR treatment. To our knowledge, this is the first case of PVR reduction with valve-in-valve despite the original valve being appropriately sized and placed.

Transcatheter Left Atrial Appendage Closure Using Intracardiac Echocardiographic Guidance From the Left Atrium.

BACKGROUND: Most commonly, left atrial appendage (LAA) occlusion procedures are performed using transesophageal echocardiography (TEE) guidance and general anaesthesia. Intracardiac echocardiography (ICE) offers potential advantages over TEE, however, ICE-guided LAA occlusion experience is limited and has been typically performed from a right-sided location where LAA visualization might be suboptimal. We sought to evaluate the efficacy and safety of percutaneous LAA occlusion using ICE guidance performed from the left atrium. METHODS: Thirty-seven patients with atrial fibrillation, significant risk for stroke, and long-term contraindication to anticoagulation underwent LAA closure with the Amplatzer Cardiac Plug (St Jude Medical, Inc, St Paul, MN) with mild sedation and ICE guidance. The ICE catheter was introduced in the left atrium through a second transseptal puncture. Patients underwent preprocedural TEE to rule out thrombus and 3-month follow-up TEE to assess occlusion grade. Patient characteristics, procedural data, effectiveness of ICE imaging, quality of occlusion, and complications were prospectively recorded. RESULTS: Procedural success was achieved in 36 of 37 patients (97%). Closure was complete or near complete (grade ≥3 according to ICE and angiography) in all cases where the device was released. In all cases, ICE imaging yielded good LAA and surrounding structure visualization and adequate procedural guidance. Three major procedural or in-hospital complications occurred. Median length of stay was 1 day. Follow-up TEE documented the absence of any residual peri-device leak in all but 1 (29 of 30) case. CONCLUSION: Initial experience suggests LAA occlusion with the Amplatzer Cardiac Plug using ICE guidance from the left atrium is feasible, reproducible, and safe.

Percutaneous paravalvular leak reduction: procedural and long-term clinical outcomes.

BACKGROUND: Significant paravalvular leak (PVL) after prosthetic replacement can result in hemolysis and/or congestive heart failure (CHF). Percutaneous PVL reduction (PPVR) represents an alternative to repeat surgery for a selected population. The purpose of this study was to assess the procedural and long-term clinical efficacy of percutaneous PPVR and its effect on survival free of rehospitalization for CHF, surgical reintervention, and death. METHODS: We analyzed a cohort of 56 consecutive patients who underwent 61 PPVRs in our institution between June 2001 and December 2010. Procedural success was defined as a reduction in regurgitation severity free from procedural complications. Patients were followed-up for vital status, clinical events, and symptoms. RESULTS: Patients were aged 65 ± 11 years, with an average logistic EuroSCORE of 19 ± 14%. Indications for PPVR included CHF (61%), hemolysis (9%), or both (30%), caused by mitral (n = 44) or aortic (n = 12) PVL. Procedural success was achieved in 75% of cases. Three major complications, including 2 deaths, occurred during the initial 30-day follow-up in the 42 patients who were treated with a device. After adjusting for the logistic EuroSCORE, prosthesis type (mitral vs aortic), and time interval since the last valve surgery, a successful PPVR was associated with a better survival free of rehospitalisation for CHF, need for surgical reintervention, and death compared with patients with a failed PPVR. (hazard ratio = 0.34; 95% confidence interval, 0.17-0.71). CONCLUSIONS: PPVR is associated with a reasonable rate of procedural success and favourable cardiovascular outcomes, and represents an appropriate option when technically possible.

Description and assessment of a common reference method for fluoroscopic and transesophageal echocardiographic localization and guidance of mitral periprosthetic transcatheter leak reduction.

OBJECTIVES: This study sought to describe and compare a novel fluoroscopic method and a 2-dimensional transesophageal echocardiographic (TEE) method to localize mitral periprosthetic leaks (PPLs) for transcatheter reduction. BACKGROUND: Transcatheter reduction of significant regurgitation represents a modern and attractive alternative to surgery for the treatment of mitral PPL in high-risk patients. Accurate localization and precise communication between the echocardiographer and the interventional cardiologist are essential for procedural success. METHODS: We analyzed TEE and fluoroscopic studies of patients with mitral PPL who underwent multiplane 2-dimensional TEE-guided transcatheter reduction in our institution. Periprosthetic leaks were routinely localized using the "surgeon's-view" time-clock method during periprocedural TEE assessments. The 2-dimensional TEE examinations were later retrospectively reviewed by an echocardiographer blinded to procedural TEE findings. A corresponding surgeon's-view time-clock method was plotted for fluoroscopic PPL localization. Using this fluoroscopic method, offline fluoroscopic images were reviewed by an independent interventional cardiologist blinded to TEE results. Agreement between methods was evaluated. RESULTS: Complete imaging data were available for analysis in 20 patients who, between 2002 and 2009, underwent transcatheter reduction in which the defect was successfully crossed. There was excellent agreement between procedural TEE and retrospective TEE review for PPL localization (100%; p < 0.0001) and between fluoroscopic and procedural TEE localization (90%; 95% confidence interval [CI]: 77% to 100%; p = 0.0003). In the 2 cases where there was disagreement, fluoroscopic PPL localization was adjacent to TEE localization. CONCLUSIONS: The surgeon's-view time-clock method of localizing PPL using 2-dimensional TEE is highly reproducible and allows fluoroscopic localization using the same reference system with very good agreement.